Brief Title
Laparoscopic Staging in Patients With Ovarian, Fallopian Tube, or Other Primary Abdominal Cancers
Official Title
LAPAROSCOPIC STAGING IN PATIENTS WITH INCOMPLETELY STAGED CANCERS OF THE OVARY
Brief Summary
RATIONALE: Laparoscopic staging may help doctors plan more effective treatment for ovarian,
primary fallopian tube, and primary abdominal cancers.
PURPOSE: Phase II trial to study the effectiveness of laparoscopic staging in patients with
ovarian, primary fallopian tube, or primary abdominal cancers who have not undergone complete
staging.
Detailed Description
OBJECTIVES: I. Determine the feasibility of laparoscopic staging of patients with
incompletely staged ovarian, primary fallopian tube, and primary peritoneal cancers. II.
Assess the adverse effects associated with this technique.
OUTLINE: Surgery. Laparoscopy with cytologic examination and lymph node sampling followed, if
feasible, by surgical resection.
PROJECTED ACCRUAL: Up to 50 patients will be accrued over approximately 2 years. If more than
4 evaluable patients cannot complete surgery, the study will be closed.
Study Phase
Phase 2
Study Type
Interventional
Condition
Fallopian Tube Cancer
Intervention
laparoscopic surgery
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Start Date
September 1993
Primary Completion Date
March 2010
Eligibility Criteria
DISEASE CHARACTERISTICS: One of the following incompletely staged malignancies: Ovarian
cancer of any cell type Primary fallopian tube carcinoma Primary peritoneal carcinoma No
clinical evidence of metastases to abdominal organs, the adnexa, or retroperitoneal lymph
nodes on CT with contrast or at prior abdominal surgery No metastases on chest x-ray No
contraindications to laparoscopy, i.e.: No bowel obstruction No ileus No peritonitis No
excessive obesity as indicated by a Quetelet Index over 35 (weight in kg/height in sqm) No
diaphragmatic hernia on chest x-ray No grade 2 heart toxicity
PATIENT CHARACTERISTICS: Age: Adult Performance status: GOG 0 or 1 Hematopoietic: WBC at
least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no more than 1.5
mg/dL AST no more than 3 times normal Renal: Creatinine no more than 2.0 mg/dL Other: No
second malignancy except nonmelanomatous skin cancer Not pregnant
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior or
concomitant chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior or
concomitant abdominal or pelvic radiotherapy Surgery: No prior retroperitoneal surgery No
more than 10 weeks since initial abdominal surgery
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Nick M. Spirtos, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00002538
Organization ID
GOG-9302
Secondary IDs
CDR0000078530
Responsible Party
Sponsor
Study Sponsor
Gynecologic Oncology Group
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Nick M. Spirtos, MD, Study Chair, Women's Cancer Center - Palo Alto
Verification Date
August 2013